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PALONOSETRON HYDROCHLORIDE

NDA

PALONOSETRON HYDROCHLORIDE | N208109 | FRESENIUS KABI USA LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Helsinn Healthcare S.A. et al v. Fresenius Kabi USA, LLC 1:2015cv00918 5 patentspalonosetron hydrochloride	D. Del.	2015-10-13	Terminated 2015-12-02	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-4664 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition requesting that the FDA designate its Palonosetron Hydrochloride Injection approved under 505(b)(2) NDA 208109 as therapeutically equivalent with an AP rating to the reference listed drug Aloxi (Palonosetron Hydrochloride Injection, NDA 021372) by	505(q)	2018-12-10	Withdrawn	Fresenius Kabi USA, LLC

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

58 trials from ClinicalTrials.gov, 1 active, 45 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Cisplatin Disposition and Kidney Injury NCT03817970	Phase 3	Active	University of Colorado, Denver	72	2019-11-15 → 2027-12-31
AMENO-2: Aprepitant Plus Palonosetron Versus Granisetron in the Prevention of Nausea and the Emesis Induced by Chemotherapy in Patients Treated With Haematopoietic Progenitors NCT00415103	Phase 4	Completed	PETHEMA Foundation	196	2006-11 → 2009-09
APF530 or Aloxi (Palonosetron Hydrochloride) Combined With Dexamethasone in Preventing Nausea and Vomiting in Patients Receiving Chemotherapy for Cancer NCT00343460	Phase 3	Completed	Heron Therapeutics	1,428	2006-06 → 2009-02
Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)NCT00967499	Phase 2	Completed	Eisai Inc.	239	2009-07-13 → 2009-12-18
Safety and Efficacy Study for the Prevention of Nausea and Vomiting in Multiple Myeloma Patients Receiving Stem Cell Transplantation.NCT00306735	Phase 2	Completed	Eisai Inc.	75	2006-03 → 2007-12
The Effects of Anesthetic Techniques and Palonosetron Administration on the Incidence of PONV NCT02809378	Phase 4	Completed	Ajou University School of Medicine	150	2016-06 → 2017-04-20
Netupitant and Palonosetron Hydrochloride in Preventing Chronic Nausea and Vomiting in Patients With Cancer NCT03040726	Phase 2/3	Completed	M.D. Anderson Cancer Center	53	2017-05-03 → 2022-02-14
Comparative Study of Palonosetron With Granisetron as a Control in Patients Receiving Highly Emetogenic Chemotherapy NCT00359567	Phase 3	Completed	Taiho Pharmaceutical Co., Ltd.	1,140	2006-07 → 2007-08
A Safety Study of Oral Netupitant and Palonosetron for the Prevention of Nausea and Vomiting NCT01376297	Phase 3	Completed	Helsinn Healthcare SA	413	2011-07
Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis NCT02625181	N/A	Completed	Vanderbilt University	27,034	2016-07 → 2017-11-30

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain15 active DMFs5 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

HAS HEALTHCARE ADVANCED SYNTHESIS SAPALONOSETRON HYDROCHLORIDE USP

DMF 160632002

NEULAND LABORATORIES LTDPALONOSETRON HYDROCHLORIDE

DMF 211232007

ALP PHARM BEIJING CO LTDPALONOSETRON HYDROCHLORIDE

DMF 232092009

TAPI NL BVPALONOSETRON HYDROCHLORIDE

DMF 233322009

DR REDDYS LABORATORIES LTDPALONOSETRON HYDROCHLORIDE USP

DMF 235902010

ROLABO OUTSOURCING SLPALONOSETRON HYDROCHLORIDE

DMF 244972010

QILU PHARMACEUTICAL CO LTDPALONOSETRON HYDROCHLORIDE USP (NON STERILE API)

DMF 246612011

EMCURE PHARMACEUTICALS LTDPALONOSETRON HYDROCHLORIDE USP

DMF 247842011

WAVELENGTH ENTERPRISES LTDPALONOSETRON HYDROCHLORIDE

DMF 247982011

APITORIA PHARMA PRIVATE LTDPALONOSETRON HYDROCHLORIDE (NON-STERILE DRUG SUBSTANCE)

DMF 259762012

MSN LABORATORIES PRIVATE LTDPALONOSETRON HYDROCHLORIDE USP [ROUTE CODE PI]

DMF 267842013

CIPLA LTDPALONOSETRON HYDROCHLORIDE USP

DMF 275282013

USV PRIVATE LTDPALONOSETRON HYDROCHLORIDE

DMF 280882015

TYCHE INDUSTRIES LTDPALONOSETRON HYDROCHLORIDE

DMF 293302015

WOCKHARDT BIO AGPALONOSETRON HYDROCHLORIDE USP

DMF 309552016

CATALENT PHARMA SOLUTIONS LLCInactivePALONOSETRON HYDROCHLORIDE 0.50 MG SOFTGELS

DMF 181872005

GLENMARK PHARMACEUTICALS LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 243512010

RANBAXY LABORATORIES LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 244482010

LIANYUNGANG RUNZHONG PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 265612012

KYONGBO PHARMACEUTICAL CO LTDInactivePALONOSETRON HYDROCHLORIDE

DMF 336132019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2018	ORIG -1	View Letter (PDF)
Dec 7, 2018	SUPPL -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Nov 21, 2017

No patent or exclusivity listings for this strength.